Senior MSAT Technologist

This is a 18-month position.

MSAT is the custodian of manufacturing process knowledge, responsible for developing product control strategies that ensure manufacturing operations remain capable, compliant, controlled, and continuously improved.

The Senior MSAT Technologist plays a critical role in overseeing all technical activities at assigned Contract Manufacturing Organizations (CMOs) within the External Manufacturing Network. As part of the Global Manufacturing Science and Technology (MSAT) organization, this role provides essential technical and operational support to ensure that the objectives of GSK’s Global Supply Chain and CMO sites are met.

Key Responsibilities:

• Deliver technical expertise directly on the shop floor at CMOs across the region.
• Contribute to Product Transfer activities aligned with business needs, following the TRA approach.
• Contribute to API and excipient material source change initiatives utilizing the MRA approach.
• Define development and validation strategies grounded in technical rationale through TRA & MRA sessions.
• Mitigate technical risks and resolve potential issues swiftly.
• Address day-to-day technical challenges, including customer complaints, deviations, and ad-hoc queries.
• Oversee Product Lifecycle Management (PLM) activities at CMOs, managing complex changes to products, processes, and equipment technologies.

Why you?

Basic Qualifications

We are looking for professionals with these required skills to achieve our goals:

• Bachelor’s degree in a scientific discipline.
• 7+ years of experience in the pharmaceutical production environment, with a deep understanding of product dosage forms and their associated manufacturing processes (OSD, OCL, sterile nebules).
• Comprehensive knowledge of drug substance and drug product control strategies, as well as unit operations.
• Proven experience managing technical activities and delivering technical solutions within a pharmaceutical production setting.
• Expertise in structured problem-solving methodologies for addressing product and process issues.
• In-depth understanding of Product Lifecycle Management, including experience with the QbD approach.
• Technical Risk Assessment capability, with demonstrated experience in technology transfer within the pharmaceutical industry.
• Material Risk Assessment capability, with expertise in material source change practices for APIs and functional excipients.
• Strong understanding of external regulatory requirements (cGMPs, ICH, FDA), as well as internal and external quality and safety standards.
• Ability to engage effectively with peers, product owners, and subject matter experts (SMEs) within the network, as well as senior professionals across scientific, engineering, and operational disciplines.

Job Posting End Date:

23 September 2024

Why GSK?

Uniting science, technology and talent to get ahead of disease together.

GSK is a global biopharma company with a special purpose – to unite science, technology and talent to get ahead of disease together – so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns – as an organisation where people can thrive. We prevent and treat disease with vaccines, specialty and general medicines. We focus on the science of the immune system and the use of new platform and data technologies, investing in four core therapeutic areas (infectious diseases, HIV, respiratory/ immunology and oncology).

Our success absolutely depends on our people. While getting ahead of disease together is about our ambition for patients and shareholders, it’s also about making GSK a place where people can thrive. We want GSK to be a place where people feel inspired, encouraged and challenged to be the best they can be. A place where they can be themselves – feeling welcome, valued, and included. Where they can keep growing and look after their wellbeing. So, if you share our ambition, join us at this exciting moment in our journey to get Ahead Together.

Contact information:
You may apply for this position online by selecting the Apply now button.

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